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FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

LifeProNow

The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.

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FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Pharmacy Times

Common adverse reactions included gastrointestinal issues, with a low discontinuation rate due to adverse drug reactions. 2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis.

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Mitomycin Intravesical Solution Receives FDA Approval for Non-Muscle Invasive Bladder Cancer

Pharmacy Times

3 The safety profile was favorable with the most common adverse effect (AE) being increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.

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Donanemab-Azbt Receives FDA Label Update With New Dosing for Alzheimer Disease

Pharmacy Times

The FDA has approved an updated label with a new recommended titration dosing schedule for donanemab-azbt (Kisunla; Eli Lilly and Company) for once-monthly amyloid-targeting therapy for adults that experience early symptomatic Alzheimer disease (AD). million individuals in the United States aged 65 and older. 3 REFERENCES 1. News release.

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9 Sneaky Thyroid Toxins Hiding in Your Home

The Thyroid Pharmacist

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns.

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STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report

STAT

and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address. Experts say that the Singulair incident highlights a flawed system, both in the U.S.